Lost in Centrifugation: Accounting for Transporter Protein Losses in Quantitative Targeted Absolute Proteomics
In drug development, considerable efforts are made to extrapolate from in vitro and preclinical findings…
Certara2014年10月1日
Time Course of Bone Mineral Density Changes with Denosumab Compared with Other Drugs in Postmenopausal Osteoporosis: A Dose-response-based Meta-analysis
Our objective was to compare the time course of bone mineral density (BMD) changes at…
Certara2014年10月1日
Cardiac Safety Research Consortium: Can the Thorough QT/QTc Study Be Replaced by Early QT Assessment in Routine Clinical Pharmacology Studies? Scientific Update and a Research Proposal for a Path Forward
The International Conference on Harmonization E14 guidance for the clinical evaluation of QT/QTc interval prolongation…
Certara2014年9月1日
Deciding on Success Criteria for Predictability of Pharmacokinetic Parameters from In Vitro Studies: An Analysis Based on In Vivo Observations
Prediction accuracy of pharmacokinetic parameters is often assessed using prediction fold error, i.e., being within 2-, 3-, or…
Certara2014年9月1日
Development of Physiologically-based Pharmacokinetic Model to Evaluate the Relative Systemic Exposure to Quetiapine After Administration of IR and XR Formulations to Adults, Children, and Adolescents
Quetiapine is an atypical antipsychotic drug with a high permeability, moderate solubility and defined as…
Certara2014年9月1日
Assessment of Tumor Growth Inhibition Metrics to Predict Overall Survival
Modeling and simulation is proposed to support drug development phase transitions in oncology. Longitudinal tumor-size…
Certara2014年8月1日
Interaction Between Domperidone and Ketoconazole: Toward Prediction of Consequent QTc Prolongation Using Purely In Vitro Information
We aimed to investigate the application of combined mechanistic pharmacokinetic (PK) and pharmacodynamic (PD) modeling…
Certara2014年8月1日
Population Pharmacokinetic Analysis of Dutogliptin, a Selective Dipeptidyl Peptidase-4 Inhibitor
Dutogliptin is a selective dipeptidyl peptidase-4 inhibitor shown to be efficacious and safe in patients…
Certara2014年7月14日
Simulation of Monoclonal Antibody Pharmacokinetics in Humans Using a Minimal Physiologically-based Model
Compared to small chemical molecules, antibodies and Fc-containing derivatives (mAbs) have unique pharmacokinetic behavior characterized by…
Certara2014年7月9日
